Evidence map›Paper›PMID 23915113›Full record

Trial reportBMC neurology2013

Interferon beta 1b following natalizumab discontinuation: one year, randomized, prospective, pilot trial.

Claudio Gobbi, Dominik S Meier, François Cotton, Martina Sintzel, David Leppert, Charles R G Guttmann, Chiara Zecca

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01144052 (De-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis), which is not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
3.6field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01144052 phase4completednot on this map

De-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis

TypeinterventionalSponsorClaudio GobbiRan2010 to 2011Enrolled19ConditionsRelapsing-remitting Multiple SclerosisArmsinterferon beta-1b, Natalizumab
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Natalizumab for multiple sclerosis.The Cochrane database of systematic reviews · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 3 countries.

Claudio GobbiNeurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Lugano, Switzerland.
Dominik S Meier
François Cotton
Martina Sintzel
David Leppert
Charles R G Guttmann
Chiara Zecca
Ospedale regionale di Lugano · CHBrigham and Women's Hospital · USHarvard University · USInserm · FRUniversity Hospital of Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNatalizumab (NTZ) discontinuation leads to multiple sclerosis reactivation.The objective of this study is to compare disease activity in MS patients who continued on NTZ treatment to those who were switched to subcutaneous interferon 1b (IFNB) treatment.

methods1-year randomized, rater-blinded, parallel-group, pilot study (ClinicalTrial.gov ID: NCT01144052). Relapsing remitting MS patients on NTZ for ≥12 months who had been free of disease activity on this therapy (no relapses and disability progression for ≥6 months, no gadolinium-enhancing lesions on baseline MRI) were randomized to NTZ or IFNB. Primary endpoint was time to first on-study relapse. Additional clinical, MRI and safety parameters were assessed. Analysis was based on intention to treat.

results19 patients (NTZ n=10; IFNB n=9) with similar baseline characteristics were included. 78% of IFNB treated patients remained relapse free (NTZ group: 100%), and 25% remained free of new T2 lesions (NTZ group: 62.5%). While time to first on-study relapse was not significantly different between groups (p=0.125), many secondary clinical and radiological endpoints (number of relapses, proportion of relapse free patients, number of new T2 lesions) showed a trend, or were significant (new T2 lesions at month 6) in favoring NTZ.

conclusionsDe-escalation therapy from NTZ to IFNB over 1 year was associated with some clinical and radiological disease recurrence. Overall no major safety concerns were observed.

Indexed as

AdultAntibodies, Monoclonal, HumanizedDisability EvaluationDouble-Blind MethodFemaleFollow-Up StudiesGadoliniumHumansImmunologic FactorsInterferon-betaInterferon beta-1bKaplan-Meier EstimateMagnetic Resonance ImagingMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingAntibodies, Monoclonal, HumanizedGadoliniumImmunologic FactorsInterferon-betaInterferon beta-1bNatalizumab

Identifiers

PMID23915113
PMCPMC3750382
OpenAlexW2116599116

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.